Importance Score: 65 / 100 🔴
FDA Reinstates Telework for Key Review Staff Amid Staffing Concerns
WASHINGTON – In a policy reversal impacting drug approvals and agency operations, the Food and Drug Administration (FDA) is once again permitting some employees to work remotely. This decision comes just weeks after mandating a full return to office, and is driven by anxieties that recent staff reductions and departures could compromise essential functions, including the critical process of approving new medications and medical products.
Policy Shift to Allow Telework
According to an internal communication obtained by news sources, FDA leadership is authorizing “review personnel and supervisors to resume telework” for a minimum of two days per week. This change in policy has been verified by three FDA employees who spoke on condition of anonymity to discuss internal matters.
Expansion Across Review Teams
The directive, circulated on Tuesday, applies to numerous drug reviewers within the agency. Staff members indicated that a similar approach has been communicated to reviewers overseeing vaccines, biotech drugs, medical devices, and tobacco products, although not consistently documented in writing.
Background: Return to Office and Subsequent Layoffs
This development is the latest illustration of the administration’s inconsistent strategy concerning the federal health workforce. Previous actions involved staff terminations, urgent efforts to rehire some individuals, and recent layoffs affecting approximately 3,400 employees – exceeding 15% of the agency’s total workforce. The initial return-to-office order resulted in challenges at the FDA’s Maryland headquarters, including overcapacity parking, crowded workspaces, and shortages of basic office supplies.
Administration’s Rationale
A spokesperson for the Health Secretary stated that the revised policy returns to “pre-COVID telework arrangements for reviewers,” emphasizing that their “read and write work output is tracked in 15-minute intervals to ensure productivity and accountability.”
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FDA’s History with Telework
While telework became widespread across many organizations during the pandemic, the FDA had embraced remote work practices nearly two decades prior. This flexibility was considered an advantageous benefit for attracting talent, particularly given that individuals in these roles could often secure higher compensation in the private sector.
Impact of Staff Reductions
The recent staff cuts affected entire divisions focused on FDA policy and regulations, the majority of the agency’s communications personnel, and teams supporting food inspectors and investigators. Senior leaders responsible for tobacco, new drugs, vaccines, and other sectors have also been dismissed or compelled to resign. Agency staff described a significant exodus of employees.
Former Commissioner’s Critique
Dr. David Kessler, a former FDA Commissioner, publicly described the reductions as “devastating, haphazard, thoughtless, and chaotic” during a congressional hearing on Wednesday.
Contradictory Statements on Staffing Impacts
Despite earlier assurances from Health Secretary Kennedy that FDA medical reviewers and safety inspectors would not be affected by plans to reduce the federal health workforce by 10,000 positions, these cuts have materialized and impacted key personnel.
Earlier Reversals
In February, the Department of Health and Human Services (HHS) had to reinstate some probationary employees who had been terminated, including hundreds of medical reviewers at the FDA. These positions are largely funded by industry fees, rather than federal appropriations.
Funding Concerns and User Fees
The combination of recent staff reductions, resignations, and retirements has generated a new concern: that insufficient FDA funding could disrupt the established system where industry partly finances agency operations through user fees.
FDA Budget and Industry Funding
Approximately half of the FDA’s almost $7 billion budget originates from fees collected from drug, device, and tobacco companies. These funds enable the agency to employ additional personnel to expedite the review process for new products. For instance, around 70% of the FDA’s drug program is supported by user-fee agreements, which require Congressional reauthorization every five years.
User Fee Agreement Implications
However, these agreements include stipulations that if the FDA’s federal funding falls below specific thresholds, companies are no longer obligated to remit fees and, in some cases, can reclaim previously paid fees. These thresholds are designed to ensure continued Congressional funding of the FDA, rather than complete reliance on private sector contributions.
Upcoming User Fee Negotiations
The FDA and industry groups are scheduled to commence negotiations later this year to renew several user-fee agreements, encompassing those for drugs and medical devices.
Industry Perspective on User Fees
“I don’t believe the agency or the regulated industry can risk the failure to reauthorize ‘user fees’,” stated Michael Gaba, an attorney advising FDA-regulated businesses.
Commissioner Makary’s Efforts to Stabilize Agency
Regardless of the underlying reasons for the telework reinstatement, former government officials suggest it indicates that newly appointed FDA Commissioner Marty Makary is attempting to stabilize staffing levels and resources. Makary recently made his first appearance at FDA headquarters shortly after the mass layoffs. The memo confirming the return to telework was reportedly approved by Commissioner Makary.
Telework as a Retention Strategy
“Dr. Makary needs to rebuild teams and reactivate the productivity engine that has been hampered by weeks of job insecurity, uncertainty, and staff shortages,” commented Steven Grossman, a former HHS official. “Reinstating commuting time as work time is a significant initial step toward achieving both objectives.”